510(k) K855112

DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS by Pacific Union Dental, Inc. — Product Code ELW

K855112 is an FDA 510(k) premarket notification submitted by Pacific Union Dental, Inc. for the device "DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS". The FDA issued a decision of Substantially Equivalent on March 6, 1986. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Pacific Union Dental, Inc. has at least 4 other 510(k) clearances on record.